MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO TCM I COOLING AND HEATING SYSTEM; TCM II COOLING AND HEATING SYSTEM

Model Number 15747

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the cooler heater unit alarmed "pump not primed" three times in a row, while the perfusionist was trying to prime the circuit.The front panel red light emitting diode (led) was lit.The unit was being set-up for an emergency heart, but the patient was not there yet.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) could not duplicate the reported alarm.The fsr installed a new pressure switch as a probable cause of the alarm.The fsr completed testing following the repair.The unit operated to manufacturer specifications and was returned to clinical use.The suspect pressure switch was returned to the manufacturer for further evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO TCM I COOLING AND HEATING SYSTEM
• Type of Device: TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3805320
• MDR Text Key: 4369778
• Report Number: 1828100-2014-00137
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15747
• Device Catalogue Number: 15747
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1